About this trial
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).
In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ER+HER2- breast cancer
Premenopausal and age <=50
T1 or T2
N1 including micrometastasis
Disqualifiers
Postmenopausal women
ER-negative breast cancer
Trial design
Single group
Treatments tested in this trial
Ovarian function suppression with endocrine treatments
Drug* Ovarian function suppression (OFS) with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years. * Either goserelin acetate or leuprorelin Acetate is allowed. * These patients are able to choose bilateral salpingo-oophorectomy instead of OFS. * Chemotherapy is omitted in these patients.
Treatment groups
Trial outcomes
Primary outcomes
Distant recurrence-free survival
The interval between the date of primary surgery and the date of last censored, or distant recurrence or death of any cause
Secondary outcomes
Recurrence-free survival (RFS)
The interval between the date of primary surgery and the date of last censored, or any type of recurrence or death of any cause
Invasive disease-free survival (iDFS)
The interval between the date of primary surgery and the date of last censored, or any type of invasive disease except thyroid cancer or death of any cause
Sponsors and contacts
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Gangnam Severance Hospital
Lead sponsor
Seoul National University
Collaborator